Monday, October 27, 2014

Last week, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research,
which reports the results of a population-based survey of smokers
followed up
after two years to determine whether e-cigarette use was associated
with higher or lower rates of smoking cessation. The study found that
intensive electronic cigarettes users at baseline were six times more
likely to quit smoking after a two-year follow-up period compared to
intermittent or non-users.

One additional important finding of this study deserves mention.

The study found a difference in the reasons for starting e-cigarette use between triers (those who only vaped one or two times), intermittent users, and intensive users (those who vaped daily for at least one month).

Among the intensive users, the overwhelming majority (87.6%) reported that they were vaping because of health concerns: they were concerned about their own health and/or wanted to quit smoking or cut down on the amount that they smoked.

Among the intermittent users, this percentage was only 53.6%, and among the triers, it was only 55.2%. Other major reasons given among the triers and intermittent users were vaping where smoking is not allowed and avoiding exposing others to tobacco smoke.

Overall, then, the most intensive users -- who were also more likely to quit successfully -- tended to be smokers who were using electronic cigarettes specifically with a health purpose in mind (usually, quitting smoking). There were fewer "ancillary" reasons for use among these intense users.

As the authors concluded: "those who did not progress to extended daily use of e-cigarettes were using them for reasons other than the desire to quit smoking."

The Rest of the Story

This highlights one of the major problems with the proposed regulation of e-cigarettes, as well as the way many anti-smoking groups are treating these products.

First, in terms of proposed regulation, the FDA's proposed deeming regulations would prohibit companies from telling the truth about their products. Companies could not point out that electronic cigarettes produce no smoke, nor could they truthfully make the point that these products are much safer than cigarettes. Beware of making a therapeutic claim, they could not point out that the primary purpose of these products is for smoking cessation. In short, the proposed regulations would prohibit companies from marketing these products truthfully: the companies would have to pretend that improving health has nothing to do with why these products exist or why one would want to use an e-cigarette instead of a real one.

This is absurd, and it needs to be changed in the final regulations. First, companies should be explicitly allowed to point out that these products contain no tobacco smoke. Second, companies should be allowed to truthfully inform consumers that vaping is much safer than smoking. Third, companies should be allowed to make a certain set of claims regarding smoking cessation. They should not be allowed to market these products as nicotine delivery devices or with the purpose of treating nicotine dependence or addiction (since these are diseases/conditions). But instead, they should be allowed to truthfully note that the primary intention of these products is to get smokers off of cigarettes. They should also be allowed to inform consumers that many smokers have successfully quit smoking using e-cigarettes. The FDA should allow this subset of claims to be made without running afoul of the Food, Drug, and Cosmetic Act (i.e., without having to reclassify their products as drugs and therefore pull them off the market while submitting a new drug application).

Second, in terms of the statements of anti-smoking groups, they should stop criticizing electronic cigarette companies for making truthful claims, such as that these products have helped many people quit smoking or that these products are much safer than tobacco cigarettes. By discouraging these types of truthful claims, the anti-smoking groups have in fact backed the e-cigarette companies into a corner: all they can do without arousing the ire of the anti-smoking groups is to market e-cigarettes as a glamorous or sexy form of tobacco use, or as a product that can be used where smoking is not allowed. This is exactly how we don't want these products to be marketed.

The rest of the story is that it isn't as simple as condemning electronic cigarette companies for using marketing that seems to appeal to young people, or which casts vaping as being glamorous or sexy. The companies have been boxed into a corner. And the ones boxing them into that corner are us! By us, I mean public health groups and agencies.

It is time to not only allow, but to encourage the truthful marketing of electronic cigarettes. Based on the current research, such an approach would actually aid the public's health by encouraging more serious vapers who would have a higher likelihood of making the complete switch from tobacco cigarettes to the much safer electronic ones.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Like its U.S. counterpart (the National Youth Tobacco Survey), the survey from Poland found a dramatic increase in experimentation with electronic cigarettes during the period 2010/11 - 2013/14. Experimentation increased from 16.8% to 62.1%.

Different from the U.S. study, however, the Poland study found very high rates of current use of electronic cigarettes, which rose from 5.5% to 29.9%.

Most alarming, and completely different from results observed in the U.S., the prevalence of cigarette smoking during the study period increased substantially, rising from 23.9% to 38.0%.

The Rest of the Story
In and of itself, the increase in electronic cigarette experimentation in Poland is to be expected. However, there are two aspects of the data which are alarming.

First, not only did experimentation rise, but the rates of current use of electronic cigarettes are substantially higher than they are in the U.S. This suggests that not only are Polish youth trying these products, but the products seem to have more of a "stick" factor than they do in the U.S.

Second, and more alarming, is the finding that the dramatic increase in electronic cigarette use is occurring in the presence of a substantial increase in cigarette smoking. This is completely unlike the situation in the U.S., where the dramatic rise in experimentation with electronic cigarettes has been associated with a decline in youth smoking to its lowest level in recent history.

As the authors point, out the combination of the dramatic increase in e-cigarette experimentation, the high prevalence of current e-cigarette use, and both in the setting of a substantial increase in smoking prevalence do not appear to be consistent with the hypothesis that the use of electronic cigarettes among youth in Poland is displacing tobacco cigarettes.

Of course, this is only a cross-sectional study so it is premature to conclude that it is the electronic cigarette use that caused the observed increase in smoking. There are many other factors which could be at play. Nevertheless, these are the type of data which would cause me concern should they appear in U.S. surveys.

There are three major takeaways from this story.

First, having seen what concerning data about e-cigarette and cigarette use among youth would look like, this should be reassuring to public health advocates in the United States, where the data look very different and do not support the conclusion that e-cigarettes are serving as any sort of gateway to cigarette smoking.

Second, it may be that country-specific policies are necessary to regulate e-cigarettes, as the products being used and the use and popularity of the products may differ from country to country. A one size fits all approach may not make sense for such a complex phenomenon with an incredible diversity of types of products.

Third, comparing how different anti-smoking groups present the results of these findings along with those of the U.S. findings should be instructive in terms of identifying potential biases.

Those who report both the U.S. findings and Poland findings as demonstrating the gateway effect of youth moving from e-cigarettes to smoking (i.e., Glantz, Dutra, etc.) are clearly biased towards presenting the negative effects of e-cigarettes, rather than the truth.

Those who report both the U.S. findings and Poland findings as great news that should spare us concerns about the use of electronic cigarettes among youth are clearly biased towards electronic cigarettes and downplaying potential risks.

Those who report the U.S. findings and Poland findings differently (with the Poland findings showing reason for concern and the U.S. findings not ringing alarm bells about any significant gateway effects) are probably presenting a much more balanced and nuanced (and less biased) picture of the scientific data.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Wednesday, October 22, 2014

As I noted yesterday, one of the most central tenets of medicine and public health is "to do
no harm." Research out of the Center for Survey Research at the
University of Massachusetts Boston suggests that policy makers and anti-smoking
groups which are supporting bans on e-cigarette flavors - such as one proposed in New York City - would be violating this principle, causing tragic consequences by
promoting smoking to a significant proportion of the population.

Monday, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research,
which reports the results of a population-based survey of smokers
followed up
after two years to determine whether e-cigarette use was associated
with higher or lower rates of smoking cessation. The study found that
intensive electronic cigarettes users at baseline were six times more
likely to quit smoking after a two-year follow-up period compared to
intermittent or non-users.

However, the survey included a very useful question for all smokers who
had tried, intermittently used, or intensively used electronic
cigarettes but discontinued e-cigarette use for some reason and returned
to smoking. Specifically, these smokers were asked to name the most
important reasons why they returned to cigarette smoking.

The number one reason given by smokers for stopping electronic cigarette use was the taste of the product. More than one-third (35.0%) of
triers reported that taste was a major factor in their discontinuation of vaping.

Very few intensive users and only a small number of intermittent users listed taste as an important consideration in discontinuing vaping. This suggests that taste is a critical aspect of the vaping experience which largely explains whether a smoker will progress to more intensive and perhaps more advanced use of these products, which are associated with a higher likelihood of smoking cessation.

The Rest of the Story

What does this mean?

It means that if electronic cigarette flavors are banned, the percentage of smokers who progress to regular e-cigarette use will plummet. Moreover, the benefits of e-cigarettes in terms of promoting smoking cessation will be largely negated. Worst of all, thousands of smokers who would otherwise have been likely to reduce their cigarette consumption or perhaps quit with e-cigarettes will instead return to cigarette smoking or never give e-cigarettes the light of day.

Simply, it would be a public health tragedy that would cost countless lives.

It would, of course, also be a huge boon for combustible cigarette profits.

Proponents of these flavoring ban proposals have failed to present a cost-benefit analysis demonstrating that these enormous costs of basically decimating the e-cigarette market would be offset by a reduction in harm to youth who are picking up e-cigarettes because of the flavor and suffering serious health consequences (presumably as a result of initiating smoking). In fact, the current evidence base does not suggest that the use of flavored e-cigarettes is causing any net harm. If anything, it appears that youth e-cigarette use might be associated with some amount of smoking reduction among youth smokers.

It is critical that before policy makers, whether in New York City or at the FDA, take the draconian step of banning electronic cigarette flavors, they demonstrate that such a measure's public health benefits would outweigh its harms. The current evidence demonstrates that the opposite is the case. There would be very little public health benefit at the expense of tragic consequences to ex-smokers, who would return to smoking in huge numbers, and to current smokers, who would continue to smoke combustible cigarettes rather than make a potentially successful quit or reduction attempt using e-cigarettes.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Tuesday, October 21, 2014

One of the most central tenets of medicine and public health is "to do no harm." Research out of the Center for Survey Research at the University of Massachusetts Boston suggests that many anti-smoking groups are violating this principle, causing tragic consequences by promoting smoking to a significant proportion of the population.

Yesterday, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research,
which reports the results of a population-based survey of smokers followed up
after two years to determine whether e-cigarette use was associated
with higher or lower rates of smoking cessation. The study found that intensive electronic cigarettes users at baseline were six times more likely to quit smoking after a two-year follow-up period compared to intermittent or non-users.

However, the survey included a very useful question for all smokers who had tried, intermittently used, or intensively used electronic cigarettes but discontinued e-cigarette use for some reason and returned to smoking. Specifically, these smokers were asked to name the most important reasons why they returned to cigarette smoking.

Sadly, the third most common reason given by smokers was concern over the health effects of electronic cigarettes. Nearly one-third (29.3%) of smokers who discontinued e-cigarette use and returned to exclusive smoking listed concern over the health effects of vaping as a very important reason for stopping e-cigarette use.

This is unfortunate because despite the propaganda being disseminated by many anti-smoking groups, vaping is much safer than smoking and there is no legitimate health concern that should lead a smoker to choose tobacco cigarettes over fake, tobacco-free ones.

I find it truly tragic that a substantial proportion of smokers who have used e-cigarettes - perhaps as many as one-third - have fallen for the propaganda of many anti-smoking groups and have discontinued their cessation or reduction attempts and returned to full-time cigarette smoking because of a concern about their health. This is completely irrational, as there is no question that switching to electronic cigarettes is much safer than continuing to smoke, and that even a major reduction in smoking has positive respiratory health consequences.

Where are these smokers getting the irrational and completely unfounded idea that a concern about their health should lead them to switch completely from vaping to smoking? The answer - and here is the sad part of the story - is that these smokers are almost certainly getting this false information from a host of supposedly "anti-smoking" groups which, as documented on The Rest of the Story over the past years, have been spreading false and misleading propaganda about the relative health effects of electronic cigarettes compared to tobacco cigarettes.

No later than yesterday did Stan Glantz again disseminate hysterical propaganda designed to scare people into thinking that the nicotine in electronic cigarettes causes heart attacks, despite the lack of any direct evidence that this is the case, and despite the fact that most scientists are unsure that the nicotine in cigarette smoke contributes to heart attacks. While Glantz provides the caveat that: "there are not yet direct evidence on the effects of e-cigarettes on the sympathetic nervous system," this is likely to be lost, given that the headline reads: "Reasons to worry about e-cig induced heart attacks."

I don't mean to single Stan out because he is joined by a host of supposedly "anti-smoking" groups. But the irony is that these groups, by disseminating propaganda that is demonstrably resulting in vapers deciding to switch completely back to smoking, are actually helping to promote cigarette smoking. Thus, it is uncomfortable to continue to refer to these organizations as "anti-smoking" groups. I do not question their intentions. However, when the effects of their actions are to promote smoking, then something is wrong.

And something needs to change. Right away.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Monday, October 20, 2014

A new study, just published online ahead of print in the journal Nicotine & Tobacco Research, reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation.

A baseline survey conducted in the Dallas and Indianapolis metropolitan areas in 2011/2012 identified 1,374 smokers who agreed to be re-contacted. Of these, 695 were successfully re-contacted in 2014. At the baseline interview, all respondents were current smokers and their use of electronic cigarettes was assessed. At the follow-up interview, smoking cessation was defined as abstinence from cigarettes for at least one month.

Smoking cessation rates were compared between intensive e-cigarettes users at baseline (daily use for at least one month), intermittent users (use more than once or twice but not daily for a month or more); and non-users (use no more than once or twice).

The chief finding was as follows: "Logistic regression controlling for demographics and tobacco dependence
indicated that intensive users of e-cigarettes
were 6 times as likely as non-users/triers to
report that they quit smoking (O.R. 6.07, 95% C.I. 1.11, 33.2). No such
relationship
was seen for intermittent users."

The Rest of the Story

This is very important research, because it demonstrates that the intensive use of electronic cigarettes is associated with greatly increased rates of smoking cessation, even among a sample of dual users (i.e., all users were smokers at baseline).

However, the study also shows that for a number of reasons, many smokers do not become intensive e-cigarette users, and these individuals do not appear to gain any benefit from e-cigarettes in terms of smoking cessation. Trying to identify the factors that impede progression to more intensive electronic cigarette use could help to discover ways to make e-cigarettes more appealing and more likely to lead to more regular and sustained use. This would in turn increase the value of these products for smoking cessation.

One difficulty in interpreting the results of the study is that different levels of use may correspond with different levels of motivation to quit. For example, it may be that intensive users are more likely to be using e-cigarettes as part of an explicit quit attempt, while intermittent users are more or less experimenting with the products or using them for some other reason. This means that the results of any survey study must be interpreted strictly with respect to the nature of the use of the product in that specific sample.

This problem explains why two previous survey studies have found that e-cigarette users had lower chances of quitting. In those studies, many of the users were likely those who were not highly motivated to quit and who were not even making a quit attempt.

This is one major reason why a clinical study of the effects of e-cigarettes on smoking behavior is so critical. There is simply no other way to equalize the levels of motivation to quit and reasons for wanting to use an alternative product.

Interestingly, this study did not find a consistent relationship between electronic cigarette use and motivation to quit. Thus, even when one measures motivation to quit explicitly, it is not clear that controlling for this variable is adequate to account for differences between groups.

What does this all mean? It means that while survey research continues to be valuable, especially when it carefully defines and compares different subsets of e-cigarette users and attempts to focus on users who are explicitly making quit attempts, there are still major limitations with this methodology that cannot be overcome. We no doubt need many more survey studies to help elucidate the complex behavioral effects of electronic cigarettes on smoking behavior. However, we also need a clinical study in which smokers at exactly the same level of motivation to quit are compared - that is, we need a randomized study in which the behavioral effects on smoking with e-cigarettes are identified and compared with another product such as NRT.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Wednesday, October 15, 2014

Some of the researchers and advocates who opposed our crowdfunding campaign to raise money for a randomized behavioral study of the effects of electronic cigarettes on smoking behavior argued that randomized clinical trials (RCTs) are simply not appropriate to study e-cigarettes because they cannot simulate the real-life situation, where smokers have many choices of different types of products, can engage with social networks, and can experiment over time, change products, advance from one type of product to another, etc.

Instead, these advocates argued that surveys are the best way to study the potential benefits of e-cigarettes. Surveys measure the real-life situation of how e-cigarettes and vapor products are actually used.

According to the argument, surveys produce valid results, while RCTs produce invalid results.

The Rest of the Story

Unfortunately, it's just not that simple.

The above argument is convenient for advocates who want to suppress "negative" or "unfavorable" findings by discouraging RCTs - which they believe will "underestimate" the effectiveness of e-cigarettes for smoking cessation and encouraging survey studies - which they believe will show the effects of vapor products in all their possible glory. However, the argument carries with it a lack of scientific validity.

The truth is that there are major advantages and disadvantages of both surveys and clinical trials to examine the potential benefits of electronic cigarettes. Both types of study designs have inherent biases which can produce results that are more "favorable" or "unfavorable." This is why the methodology of published research needs to be examined so carefully. It is not so simple as to dismiss RCT evidence and accept survey evidence. One needs to consider the strengths and limitations inherent in both approaches. And at the end of the day, the only defensible approach, I believe, is that both types of studies are necessary, and we must carefully interpret and synthesize the findings from studies of multiple designs, using the totality of the evidence to make final judgments about the benefits of electronic cigarettes.

This is why I find it so troubling that some major voices in the e-cigarette community are arguing that RCTs should not be conducted and only survey studies are of value.

The randomized study provides a number of important benefits that can never be realized in a survey study. Most importantly, the RCT can equalize between study groups the known and unknown confounding variables that may lead to invalid study results.

For example, one of the major problems in some of the previous survey studies of electronic cigarettes (the ones cited by Stan Glantz, for example) is that they fail to control for a major confounder: the level of a smoker's addiction to smoking and motivation to quit. Some of the studies that Glantz has cited to show that e-cigarettes are ineffective for smoking cessation compare users of e-cigarettes and non-users of e-cigarettes. In two of these studies, those who did not use e-cigarettes had higher quit rates.

The problem is that the smokers who used e-cigarettes were likely more heavily addicted and more resistant to quitting. The reason they tried e-cigarettes was probably related to their failure to quit smoking using other types of therapy, such as NRT or other drugs. E-cigarettes, after all, are not generally the first smoking cessation approach that a smoker will try.

The impact of this confounding is that it will bias the results towards finding that e-cigarettes are much less effective than other approaches. In fact, this is exactly what happened and it is the reason why the evidence that Glantz and others are citing to support their contention that e-cigarettes hinder smoking cessation is invalid.

The beauty of a randomized study is that it can equalize the levels of smoking addiction, reasons for wanting to quit, and motivation to quit across groups. In addition, it equalizes other confounders, including unknown confounders which could affect the study results. There is no way for a survey study to accomplish this. Thus, to simply throw out the RCT is quite unscientific, in my opinion. It throws out one of the most valid pieces of evidence that is necessary to make an informed judgment about the effect of these products: the differences in effectiveness of the products under conditions in which confounding cannot throw off the results.

A second major advantage of a clinical trial is that it can examine the potential effectiveness of interventions in which the use of a product is promoted for use among smokers who are interested in quitting. A survey cannot do this, because it can only examine the use of products under current conditions. It provides no information on what would happen if the product was actively promoted to a group of smokers, as it is in a clinical trial.

A third major advantage of a clinical trial is that conditions are controlled as carefully as possible, minimizing potential biases. Both sampling and measurement bias are greatly reduced, if not eliminated. In contrast, survey studies are generally subject to significant sampling and measurement bias.

There are some specific problems with survey studies that could lead to an overestimation of the benefits of electronic cigarettes. One major problem is that a survey study of the use of advanced vapor products would result in a severe bias towards finding a high level of effectiveness of these products. The reason? By the time smokers advance to use products like open-ended systems, they have already experienced success, fulfillment, and enjoyment with vaping. In other words, limiting the sample to users of advanced vapor products filters out the majority of e-cigarette users, who do not experience great success and therefore don't go on to the more advanced products.

Although the survey approach described above would lead to "invalid" results, I would never argue that survey studies should be thrown out and that we should only be conducting RCTs. My point is that there are strengths and limitations of various study designs, and causal inference is enhanced by having research evidence from multiple study designs. On balance, the strengths and weaknesses balance each other out, leading to a much greater ability to draw valid conclusions.

Neither the survey approach or the RCT approach is perfect. Both have major strengths and significant limitations. The best way to proceed is to conduct both types of studies and to synthesize the results across study designs, keeping in mind the methodological strengths and limitations of each individual study. Only by looking at this totality of the evidence can we draw valid scientific conclusions.

And this is why when some responded to our proposal for a randomized behavioral study by arguing that such an approach was invalid and that we should do a survey instead, I viewed those responses as being unscientific and unsound. Instead, I believe what is truly behind these draconian opinions (draconian because they would throw out an entire line of potential evidence) is a bias towards electronic cigarettes. I'm not arguing that it is a conscious bias. It may be subconscious. But I don't believe that any objective scientist would argue for completely throwing out a randomized clinical study design and relying solely on survey evidence to draw conclusions about the effectiveness of a product such as electronic cigarettes.

Finally, while it is true that the typical RCT is limited because it does not simulate the real-life situation where smokers can choose between different products, change products over time, and engage in social networks to support their vaping, the study we had proposed would have allowed for all of these things. We would have given smokers a wide range of products to choose from and allowed them to experiment with different products and make changes if they desired, and we would have referred them to a number of vaping web sites and support groups. In fact, we had decided to include a training and information session with an actual vaper as part of the study. This would still not have simulated the real-life situation exactly, but it would have significantly helped to make the study more meaningful by making it more similar to what happens in "real life."

I believe that such a modified, randomized clinical study is essential to add another line of evidence with which to evaluate the potential benefits of electronic cigarettes. Yes, there are limitations to RCTs, but it makes no sense to throw out the baby with the bath water.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

The study - a prospective cohort study of 1560 adult smokers who were surveyed at baseline and 6 month follow-up and made at least one quit attempt between the two interviews - compared the quit rates for the use of prescription medication with specialist behavioral support, prescription medication with brief advice from their physician, over-the-counter NRT, and none of these (no use of medication).

The main outcome measure was sustained abstinence from the last quit attempt to the time of the survey. The analysis controlled for demographic variables as well as baseline level of cigarette dependence.

The results were as follows: "Compared with smokers using none of the cessation aids, the adjusted
odds of remaining abstinent up to the time of the 6-month follow-up
survey were 2.58 (95% CI, 1.48-4.52) times higher in users of
prescription medication in combination with specialist behavioral
support and 1.55 (95% CI, 1.11-2.16) times higher in users of
prescription medication with brief advice. The use of NRT bought over
the counter was associated with a lower odds of abstinence (odds ratio, 0.68; 95% CI, 0.49-0.94)."

Regarding the use of over-the-counter NRT, the study concludes: "The most frequently used form of treatment, NRT bought over the counter, appears to be associated with reduced success rates."

The Rest of the Story

This study adds to the growing evidence that while NRT is more effective than placebo in clinical trials, the real-life use of NRT is not necessarily associated with improved cessation outcomes. In this study, the researchers found that the use of over-the-counter NRT was actually associated with lower smoking cessation rates than quit attempts that did not involve the use of any medication.

The authors suggest that the reason for the failure of over-the-counter NRT in real life, but its effectiveness in clinical trials, is most likely the fact that in the clinical trials, there is intensive intervention outside of the drug, including instructions on how to use the medication, multiple study visits to help maintain adherence with medication use and the quit attempt, and consistent, long-term monitoring. As the authors argue: "This is a different situation from the real-world setting of our study in which smokers use the medication in an uncontrolled yet more realistic fashion."

The authors note that these findings are consistent with their earlier study, in which "NRT bought over the counter was equally associated with the success of
quitting than not using treatment ... (adjusted odds
ratio, 0.96; 95% CI, 0.81-1.13)."

Another possible reason why NRT is effective in clinical trials but may not be nearly as effective in real-life settings is that the clinical trials are not truly blinded. Many subjects receiving placebo are immediately aware that they are not receiving nicotine replacement and have a higher tendency to quickly give up on their quit attempt in frustration that they were assigned to the placebo arm of the study.

While the study did find a benefit of prescribed smoking cessation medication, especially in combination with specialist behavioral intervention, the reality remains that the most common form of NRT usage is over-the-counter purchase outside the setting of intensive behavioral intervention or physician advice and guidance. Thus, the "real world" effectiveness of NRT is brought into serious question by the results of this study.

In the context of their previous study showing that "real life" use of electronic cigarettes is associated with enhanced smoking cessation rates compared to the use of NRT, it appears that the existing evidence from survey studies suggests that electronic cigarettes may actually be more effective than NRT in real-life circumstances (i.e., outside the context of clinical trials).

I believe that what is needed urgently are randomized behavioral studies that directly compare electronic cigarettes head-to-head against over-the-counter NRT.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Thursday, October 09, 2014

The UK's Committee of Advertising Practice (CAP) has announced new rules, effective on November 10, which restrict electronic cigarette advertising.

According to CAP:

"In summary, the rules state:

Ads must not be likely to appeal particularly to people under
18, especially by reflecting or being associated with youth culture

People shown using e-cigarettes or playing a significant role must neither be, nor seem to be, under 25

Ads must not be directed at people under 18 through the selection of media or the context in which they appear

Ads must not encourage non-smokers or non-nicotine users to use e-cigarettes

Ads must make clear that the product is an e-cigarette and not a tobacco product

Ads on TV and radio will be subject to scheduling restrictions to
reduce the chance of e-cigarette advertisements being seen or heard by
children. Furthermore, unless manufacturers obtain an authorisation for
their product from the Medicines and Healthcare products Regulatory
Agency, ads for e-cigarettes cannot convey health benefits or claim that
they are ‘safer’ or ‘healthier’ than smoking tobacco."

The Rest of the Story

While many of these restrictions are reasonable, the final restriction mentioned - the prohibition on electronic cigarette companies claiming that these products are safer than tobacco cigarettes - is both inappropriate and devastating to the public health interest.

The restriction is inappropriate because it prohibits companies from simply telling consumers the truth about the relative safety of their products. Arguably, this is the single most important piece of information that every consumer needs to know. Keeping consumers in the dark about the relative safety of electronic cigarettes vs. tobacco cigarettes does not serve any public health interest. In fact, it does just the opposite.

By blocking e-cigarette companies from telling the truth to consumers, CAP has completely undermined the very purpose of electronic cigarette marketing. The only reason these products are on the market and being used extensively in the first place is that they are much safer than regular cigarettes. If they weren't safer than cigarettes, there would be no justification for these products to even remain on the market. Moreover, they would not have become so popular among smokers because no one is going to switch to a product that delivers less nicotine unless it has health benefits.

The relative safety of e-cigarettes over tobacco cigarettes is their primary selling point.

Destroying this selling point helps no one except for the UK's cigarette companies, which stand to enjoy a bigger run of profits due to CAP's stupidity.

The major purpose of regulating advertising in the first place is to prohibit companies from deceiving consumers. But by precluding companies from telling consumers the truth, the CAP's regulations actually ensure that consumers are deceived. There is no legal nor public health justification for this campaign of deception. It protects cigarette profits at the expense of the lives and health of UK citizens.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Wednesday, October 08, 2014

According to an article in the New York Daily News, New York City councilman Costa Constantinides (D-Queens) yesterday introduced legislation that would ban the sale of all flavored electronic cigarettes.

According to the article: "Councilman Costa Constantinides (D-Queens) will introduce legislation
Tuesday to ban the fruity flavors, saying they entice kids to start
puffing on the devices. “These flavors are direct marketing to children,” Constantinides said.
“They appeal to children, and we’re taking them out of that market.” ... “These guys are not in the quitting business. They’re in the addiction business,” Constantinides said."

The Rest of the Story

Actually, these "guys" are in the quitting business, not the addiction business. The overwhelming majority of electronic cigarette users are people who are already addicted to cigarette smoking. And the reason they are using these products is because they want to overcome their addiction to smoking. They want a safer product that can help them get off cigarettes, or at least to greatly reduce their cigarette consumption in order to protect their health. Very few never smokers are regular electronic cigarette users, and there is at present no evidence that the use of electronic cigarettes leads to nicotine or smoking addiction in anyone who was not already a tobacco user.

Banning the sale of flavored electronic cigarettes would be tantamount to a ban on virtually all electronic cigarettes. In reality, virtually every electronic cigarette product is flavored. Even the "tobacco" type of electronic cigarette is actually a flavored product, since flavorings are generally used to create that "tobacco" taste. Otherwise, the only ingredients in electronic cigarettes are nicotine, propylene glycol, and glycerin.

Councilman Constantinides' desire to take flavored electronic cigarettes off the market may be motivated by a legitimate desire to protect kids from addiction, but the reality is that his proposal would greatly increase smoking addiction in New York City by removing from the market a product that is helping thousands of New Yorkers to eliminate their smoking addiction or at least to greatly reduce the level of that addiction.

Jacob Sullum provides an excellent review of the literature on this topic, pointing out that there is very strong data to demonstrate that the flavors are what attract many smokers to try to quit using electronic cigarettes. You have to read his whole column, but to summarize:

"Whether or not they
appeal to minors, the flavors that offend him
appeal to adults who switch from smoking to vaping. In a
survey conducted by
E-Cigarette Forum last summer, three-quarters of adult vapers
favored flavor categories other than tobacco, including fruit (31
percent), bakery/dessert (19 percent), and savory/spice (5
percent).
Sales data from Palm Beach Vapors, a chain of 14 stores
that sell vaping equipment and liquids to adults only, confirm that
supposedly juvenile flavors are popular with adults. Last fiscal
year, only two of the chain's top 19 sellers were tobacco flavors.
They finished 18th and 19th, far below flavors such as strawberry,
watermelon, and cinnamon."

Sullum concludes: "Critics like Constantinides and
Sen. Jay Rockefeller (D-Va.), guided by little more than their
own idiosyncratic tastes, want to decree which flavors adult vapers
may consume, even at the cost of deterring smokers from quitting.
"Studies show that e-cigarettes, particularly flavored kinds, are
effective at helping smokers move away from combustible
cigarettes," says Gregory Conley, president of the American Vaping
Association. "The AVA supports common-sense regulation of its
products, such as New York City's existing ban on [sales] to
minors. But adults are free to make their own choices." For
now."

Hopefully, the New York City Council will vote down this proposal. If policy makers are interested in protecting kids from electronic cigarettes, they should focus on regulating the sale and marketing of these products - just as we do with the real cigarettes. It makes no sense to ban the entire product category, especially when we know these products are helping many smokers quit or cut down and when there is no evidence that the use of these products is causing youth to become addicted to smoking, or even to e-cigarette use itself.

The saddest part of the story is that while Councilman Constantinides is so concerned about youth "addiction" that he is willing to ban electronic cigarettes, he expressed no similar desire to ban the real ones. That's not public health leadership. It's political cowardice, and hypocrisy.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Thursday, October 02, 2014

For several years, I have repeatedly written about how the debate over harm reduction, especially electronic cigarettes, has brought out personal attacks, distortion of the science, and even lies among a number of opponents of this novel approach to smoking cessation. Over the past several days, I have learned that there is venom on both sides of the debate, and I had a chance to experience that venom from supporters of harm reduction.

If you read the comments to yesterday's post, in which I opine that it is time for Major League Baseball to ban the use of smokeless tobacco by its players during games, you'll see that I was battered by a number of harm reduction advocates. This battering also took place on Twitter and Facebook, where further pot shots were taken.

The interesting thing is that these attacks were in response to two very simple contentions:

1. That there is a causal link between traditional smokeless tobacco use and oral cancer; and

2. That Major League Baseball should follow the lead of the minor leagues and ban the use of smokeless tobacco, such as not to set a bad example for the millions of youth who idolize these athletes and are viewing on television or at the ballpark.

The Rest of the Story

This demonstrates just how contentious harm reduction debates are, especially in tobacco control. Both sides are acting on zealous idealism, with science playing very little role.

The ironic thing is that no one actually disagreed with me on the science. Most of the advocates of smokeless tobacco acknowledged that there is a small, but real, causal relationship between traditional smokeless tobacco use and oral cancer (this relationship does not appear to hold for snus). However, simply because I made the statement that this causal link exists, I was blasted. Apparently, the simple statement that smokeless tobacco causes oral cancer is too much for many harm reduction advocates to tolerate.

As I found out when I simply proposed the rather benign, but crucial to science, idea of conducting a clinical trial to examine the effects of electronic cigarettes on smoking behavior (in comparison to the nicotine patch, a well-accepted standard), there is very little room for balanced, objective thinking in the current tobacco control/harm reduction environment. The simple proposal to conduct such a crucial study brought out personal attacks and profound criticism. This despite the fact that every single electronic cigarette company representative I talked to about the proposal felt that the study was critical and needs to be conducted. There was no opposition to conducting sound science among the electronic cigarette companies. All the opposition came from the harm reduction "community."

The impression I am left with is that the entire harm reduction debate is a toxic one, with venom on both sides, which is leading to irrational thinking, blind adherence to ideology, a focus on ad hominem attacks rather than rational scientific discourse, and a biased perspective on the scientific evidence.

This polarization is a disappointment to me, but I guess in an era where ideological-driven debates are raging over climate change, gun control, and immunization, I should not have expected this one to be any different.

I can only hope that science will be restored to its rightful place in tobacco control and public health. But right now, I am not at all optimistic.

Wednesday, October 01, 2014

This summer, former Boston Red Sox pitcher Curt Schilling announced that he had undergone treatment for oral cancer, which he clearly attributes to this 30-year history of smokeless tobacco use (he was not a smoker).

"Curt Schilling said
Wednesday that he believes his use of smokeless tobacco led to oral
cancer that required radiation and chemotherapy. Schilling revealed the
type of cancer he had while speaking on WEEI Radio during the Boston
station's annual fund-raising broadcast for the Jimmy Fund. "I do believe without a doubt, unquestionably, that chewing is what gave me cancer," he said. During the broadcast, Schilling issued a warning to smokeless tobacco users. "It's like being given a death sentence without committing a crime," Schilling said. ... Schilling, who pitched in the Majors for 20 years, said that he used
smokeless tobacco for 30 years and that he had been unable to kick the
habit despite pain associated with it. "It's a dangerously addictive habit that I wish I had never done," Schilling said."

According to the American Cancer Society:"Oral tobacco products (snuff or chewing tobacco) are linked with cancers
of the cheek, gums, and inner surface of the lips. Using oral tobacco
products for a long time poses an especially high risk. These products
also cause gum disease, destruction of the bone sockets around teeth,
and tooth loss. It is also important for people who have been treated
for oral cavity or oropharyngeal cancer to give up any oral tobacco
products."According to the National Cancer Institute:"Smokeless tobacco causes oral cancer, esophageal cancer, and pancreatic cancer."

The Rest of the Story

I think it is high time that Major League Baseball declare a ban on the use of smokeless tobacco products during all formal MLB activities (including games and practices/warmups at which the public is present). Like smoking, the use of smokeless tobacco by major league baseball players sets a bad example for the thousands of youth watching in the stadium as well as the millions who may be watching on television. Smoking is not allowed during games. Neither should smokeless tobacco use.

The use of smokeless tobacco has already been banned in minor league baseball (in 1993). Now is the time for Commissioner Bud Selig to take the next step, the right step, and ban smokeless tobacco use as well.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.